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FDA GRAS

Science: FDA GRAS

Quercegen Pharmaceuticals received GRAS Status for its QU995(tm) Quercetin with purity greater than 99.5%

Quercegen Pharmaceuticals LLC, producer of plant-based nutrients for the pharmaceutical and nutraceutical industries and marketer of Q-Force™, was notified that QU995™, The World’s Purest Quercetin™, received GRAS (“Generally Recognized As Safe”) notified status on November 22, 2010 under U.S. Food and Drug Administration GRAS Inventory number GRN 341. Read full Press Release
 
Click here for link to Agency Response Letter indicating the GRAS notification

The Company’s GRAS Notification Dossier for QU995™ was assembled in collaboration with Cantox Health Sciences of Canada, Toxicology Regulatory Services of Virginia and other commercial partners before being submitted to the FDA in May 2010 and FDA GRAS was notified with a Letter of No Objection from FDA dated November 22, 2010. An application is pending in the EU for permission to sell QU995™ in food products in Europe. Quercetin is already approved as a food additive in Japan and is accepted as a supplement in the UK, the Netherlands and Poland.

At pre-GRAS notification meetings, a comprehensive safety review on Quercetin was requested by the FDA and EFSA. The Safety Review was published in Food and Chemical Toxicology in 2007 and concluded that Quercetin, in the doses contemplated for consumer usage, was without safety concern. Also in response to the FDA, the Company, in partnership with Merck KgAa, commissioned an independent study that demonstrated that Quercetin is non-mutagenic in-vivo. The results of this study were published in Mutagenicity in May 2008. The Company, with assistance from commercial partners, conducted a number of drug-drug interaction studies in 2009 and 2010 with no adverse effects being seen at the recommended dose of up to 1.5 grams of Quercetin per day.